510(k) · Cleared
ClearedVolker Hospital Bed, Model K960
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Volker Healthcare, Inc. · FNL Bed, Ac-Powered Adjustable Hospital
Cleared on Aug 29, 1997 after an 85-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Aug 29, 1997
- Review
- 85 days
- Class
- Class II
- Product code
- FNL
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FNL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FNL device
- #1 K202964 iBed Wireless with iBed Mobilescore 2.4 · 4 generations · no Class I recall
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All FNL devicesFNL Bed, Ac-Powered Adjustable Hospital: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FNL
1in 2021
2026 to Oct 25, outlined.
Median 510(k) review, days · FNL
Too few FNL 510(k)s in any year since 2007 to give a median.
Recalls per year · FNL
1in 2024
Class I (2 since 2007) Class II/III not classified
Adverse event reports per year · FNL
2,748in 2025
MAUDE reports naming product code FNL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 2 | 133 |
| 2008 | 0 | — | 8 | 4,482 |
| 2009 | 0 | — | 16 | 7,460 |
| 2010 | 1 | — | 6 | 12,462 |
| 2011 | 0 | — | 7 | 12,599 |
| 2012 | 0 | — | 9 | 14,612 |
| 2013 | 0 | — | 4 | 13,473 |
| 2014 | 0 | — | 4 | 5,887 |
| 2015 | 0 | — | 1 | 3,036 |
| 2016 | 0 | — | 1 | 2,075 |
| 2017 | 0 | — | 0 | 1,047 |
| 2018 | 0 | — | 2 | 1,214 |
| 2019 | 0 | — | 1 | 1,113 |
| 2020 | 0 | — | 0 | 1,106 |
| 2021 | 1 | — | 0 | 1,377 |
| 2022 | 0 | — | 2 (1) | 1,118 |
| 2023 | 0 | — | 15 | 2,185 |
| 2024 | 0 | — | 1 | 2,327 |
| 2025 | 0 | — | 0 | 2,748 |
| 2026 | 0 | — | 1 (1) | — |
What is it indicated for?
This device is intended for medical purposes in hospitals or nursing homes for use by the staff or patients to adjust the height and surface contour of the bed using built-in electric motors. The device includes moveable and latchable side rails and wheels for movement of the bed to different locations. This bed is not intended for use on patients younger than 12 years of age.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K972115 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972115: Volker Hospital Bed, Model K960.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972115
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026